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一项针对胃癌合并癌性腹膜炎或细胞学检查阳性患者的细胞减灭术、胃切除术及腹腔热灌注化疗的II期试验。

A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology.

作者信息

Badgwell Brian, Ikoma Naruhiko, Murphy Mariela Blum, Wang Xuemei, Estrella Jeannelyn, Roy-Chowdhuri Sinchita, Das Prajnan, Minsky Bruce D, Lano Elizabeth, Song Shumei, Mansfield Paul, Ajani Jaffer

机构信息

Department of Surgical Oncology, Unit 1484, MD Anderson Cancer Center, Houston, TX, USA.

Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.

出版信息

Ann Surg Oncol. 2021 Jan;28(1):258-264. doi: 10.1245/s10434-020-08739-5. Epub 2020 Jun 17.

DOI:10.1245/s10434-020-08739-5
PMID:32556731
Abstract

BACKGROUND

Current national guidelines do not include hyperthermic intraperitoneal chemoperfusion (HIPEC) as treatment for gastric cancer, and there are no completed clinical trials of cytoreduction, gastrectomy, and HIPEC from the US.

METHODS

Patients with gastric adenocarcinoma and positive peritoneal cytology or carcinomatosis who had completed systemic chemotherapy and laparoscopic HIPEC underwent cytoreduction, gastrectomy, and HIPEC with 30 mg mitomycin C and 200 mg cisplatin. The primary endpoint was overall survival (OS), with a secondary endpoint of postoperative complications (NCT02891447).

RESULTS

We enrolled 20 patients from September 2016 to March 2019. Six patients had positive cytology only and 14 had carcinomatosis. All patients were treated with systemic chemotherapy with a median of eight cycles (range 5-11 cycles) and at least one laparoscopic HIPEC. The median peritoneal carcinomatosis index at cytoreduction/gastrectomy/HIPEC was 2 (range 0-13). After surgery, the 90-day morbidity and mortality rates were 70% and 0%, respectively. Median length of hospital stay was 13 days (range 7-23 days); median follow-up was 33.5 months; median OS from the date of diagnosis of metastatic disease was 24.2 months; and median OS from the date of cytoreduction, gastrectomy, and HIPEC was 16.1 months. 1-, 2-, and 3-year OS rates from the diagnosis of metastatic disease were 90%, 50%, and 28%, respectively.

CONCLUSIONS

Survival rates for patients with gastric adenocarcinoma and peritoneal disease treated with cytoreduction, gastrectomy, and HIPEC are encouraging; our early results are similar to those of recent prospective registry studies. Multi-institutional and cooperative group trials should be supported to confirm survival and safety outcomes.

摘要

背景

当前国家指南未将腹腔热灌注化疗(HIPEC)纳入胃癌治疗方法,且美国尚无关于肿瘤细胞减灭术、胃切除术及HIPEC的完整临床试验。

方法

胃腺癌且腹膜细胞学检查呈阳性或有癌转移的患者,在完成全身化疗及腹腔镜HIPEC后,接受肿瘤细胞减灭术、胃切除术,并使用30毫克丝裂霉素C和200毫克顺铂进行HIPEC。主要终点为总生存期(OS),次要终点为术后并发症(NCT02891447)。

结果

2016年9月至2019年3月,我们招募了20名患者。6名患者仅腹膜细胞学检查呈阳性,14名有癌转移。所有患者均接受全身化疗,中位数为8个周期(范围5 - 11个周期),且至少接受一次腹腔镜HIPEC。肿瘤细胞减灭术/胃切除术/HIPEC时的腹膜癌转移指数中位数为2(范围0 - 13)。术后,90天发病率和死亡率分别为70%和0%。中位住院时间为13天(范围7 - 23天);中位随访时间为33.5个月;从转移性疾病诊断日期起的中位OS为24.2个月;从肿瘤细胞减灭术、胃切除术及HIPEC日期起的中位OS为16.1个月。从转移性疾病诊断起的1年、2年和3年OS率分别为90%、50%和28%。

结论

接受肿瘤细胞减灭术、胃切除术及HIPEC治疗的胃腺癌及腹膜疾病患者的生存率令人鼓舞;我们的早期结果与近期前瞻性注册研究的结果相似。应支持多机构和合作组试验以确认生存和安全结果。

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